Senior Product Development Engineer -Mechanical Engineering (Hybrid Boston) (IVD and Med Dev Exp preferred)

Haemonetics Interventional Technologies; Boston (MA); On-site; USD 78,000 - 133,000; Full time

Benefits offered by this job

401(k) with up to 6% employer match

Employee stock purchase plan

Flexible time off

Vacation and sick time benefits

Parental leave

Tuition reimbursement

Job summary

Haemonetics Interventional Technologies in Boston seeks a Senior Product Development Engineer with strong mechanical design to lead disposable device components for an in‑vitro diagnostic platform. You will own plastic part design, injection molding considerations, drawings, tolerances, and design transfer for high‑volume manufacturing.

The role partners with suppliers and contract manufacturers in a regulated medical device setting, developing verification strategies and design control

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, or related technical discipline.
• 5+ years in medical device or regulated product development.
• Experience with mechanical component design, injection molded parts, CAD and drawings.
• Experience collaborating with suppliers and contract manufacturers.

Responsibilities

• Lead mechanical design of disposable components from concept through production.
• Design plastic components for high‑volume manufacturing and injection molding.
• Collaborate with suppliers, tooling vendors, and contract manufacturers to resolve issues.
• Own sustaining activities and lead design change processes.
• Develop verification strategies, test protocols, and design control documentation.
• Work across engineering, quality, regulatory, procurement, and commercial teams.

Skills

Mechanical design

Cross-functional communication

Supplier collaboration

Technical problem solving

Data-driven decision making

Leadership in design/manufacturing

Education

Bachelor's degree in Mechanical Engineering

Biomedical Engineering background

Tools

SolidWorks

Job description

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Summary

We are seeking a Senior Product Development Engineer with strong mechanical design experience to lead the design and development of disposable device components for an in‑vitro diagnostic platform. This role requires hands‑on ownership of plastic part design, injection molded components, design specifications, drawings, tolerance analysis, verification planning and design transfer for high‑volume disposable manufacturing. The ideal candidate will combine strong mechanical design fundamentals with experience working directly with suppliers, tooling vendors, and contract manufacturers in a regulated medical device environment.

Key Responsibilities

• Lead mechanical design of disposable device components from concept through production, including CAD modeling, design specifications, drawings, tolerance analysis, GD&T, and verification planning.
• Design plastic components for high‑volume manufacturing, with emphasis on injection molding, manufacturability, dimensional control, component robustness, cost, and scalability.
• Partner with suppliers, tooling vendors, and contract manufacturers to evaluate design tradeoffs, resolve manufacturability issues, support process validation, and transition designs into production.
• Own sustaining activities for disposable components and serve as the technical lead for manufacturing and supplier component performance issues, including design change requests.
• Develop and execute verification strategies, test protocols, engineering studies, and reports to demonstrate performance against design requirements.
• Create and maintain design control documentation, including requirements, specifications, drawings, risk documentation, design reviews, investigations, and regulatory inputs.
• Collaborate across engineering, manufacturing, quality, regulatory, procurement, and commercial teams while providing technical guidance to junior engineers and cross‑functional partners.

Primary Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline.
• 5+ years of product development experience in medical device, IVD, life sciences, diagnostics, or another regulated product development environment.
• Demonstrated experience with mechanical component design, plastic part design, injection molded components, high‑volume disposable manufacturing, CAD, engineering drawings, verification testing, and design transfer; Proficiency with 3D CAD tools such as SolidWorks and experience with engineering drawings, BOMs, ECOs, and PLM or document control systems.
• Experience working with suppliers, tooling vendors, and contract manufacturers to support part qualification, manufacturing transfer, and production issue resolution.

Preferred Qualifications

• Experience with microfluidic, cartridge‑based, fluidic, electromechanical, or disposable diagnostic systems.
• Familiarity with design controls, risk management, verification and validation, process validation, and regulated medical device documentation.

Skills & Competencies

Strong mechanical design judgment, clear cross‑functional communication, supplier collaboration, technical problem solving, data‑driven decision‑making, and the ability to lead ambiguous design and manufacturing challenges.

Pay Transparency

Pay Transparency: The pay range for this role is: $78,400.00-$133,400.00/Annual

The base pay actually offered to the successful candidate will take into account, without limitation, the candidate’s location, education, job‑knowledge, skills, and experience in prior relevant roles.

Incentives may also be provided as part of Haemonetics’ employee compensation.

For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms.

For non‑sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms.

Employees may also be eligible to participate in the Company’s long‑term incentive plan, with eligibility and target amount dependent on the role.

In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks’ vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short‑and long‑term disability insurance, tuition reimbursement, and/or health and welfare benefits.

Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting.

If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. – 5 p.m. ET or email [e-mail].

EEO Policy Statement

Throughout our history, we have earned a solid reputation for product innovation, technical expertise, and operational excellence. Today, our products, internal research and development, marketing partnerships, and product acquisitions reflect our unwavering commitment to provide safe and available blood for patient transfusions and for use in pharmaceuticals. We rely on our talented global workforce to help us achieve our mission of providing innovative medical devices that advance the safety, quality, and availability of the world’s blood supply. To achieve our business goals and objectives, we are committed to attracting and retaining the best and brightest talent while offering a challenging, dynamic, and exciting work environment that offers professional growth and development.